BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1211059 · Received October 24, 2008

    Report

    Report Number
    2182207-2008-06873
    Event Type
    Injury
    Date Received
    October 24, 2008
    Report Date
    September 30, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: GSTALTNER K, ROSEN H, HUFGARD J, MARK R, SCHREI K, SACRAL NERVE STIMULATION AS AN OPTION FOR THE TREATMENT OF FAECAL INCONTINENCE IN PATIENTS SUFFERING FROM CAUDA EQUINA SYNDROME. SPINAL CORD. 2008; 46(9):644-647. CAUDA EQUINA SYNDROME (CES) IS A LESION OF THE PERIPHERAL NERVOUS SYSTEM WHICH CAN OCCUR IN PATIENTS SUFFERING FROM CES AS A RESULT OF A TRAUMA IN THE REGION OF THE LUMBAR SPINE. CLINICALLY, IT INVOLVES FLACCID PARESIS OF THE STRIATED MUSCLES DISTAL TO THE LESION, THE PELVIC FLOOR AND THE BLADDER. LOSS OF FUNCTION AND TONUS OF THE EXTERNAL SPHINCTER AS WELL AS PARAESTHESIA CAN ALSO BE SEEN. IT WAS OUR AIM TO IMPROVE SPHINCTER FUNCTION AND ANAL SENSITIVITY TO ACHIEVE VOLUNTARY RECTAL DEFAECATION. IMPLANT OF THE PERMANENT SNS SYSTEM WAS CARRIED OUT IN SOME PATIENTS. IN ALL CASES ONE TINED LEAD ELECTRODE WAS IMPLANTED. THE POST-OP PROCESSES TOOK PLACE WITHOUT ANY COMPLICATIONS AND ALL PATIENTS WERE FOLLOWED UP FOR A MIN OF 1 YR. REPORTABLE EVENT: ONE PATIENT SHOWED A MINIMAL LEAKAGE OF CEREBROSPINAL FLUID FOLLOWING THE PNE PROCEDURE. THIS WAS PRESUMABLY CAUSED BY MALPOSITION OF THE NEEDLE DUE TO ALTERED ANATOMY OF THE SACRUM STEMMING FROM A PREVIOUS FRACTURE OF THE PELVIS. AFTER THE REMOVAL OF THE NEEDLE, THERE WERE NO FURTHER SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC NEUROMODULATION 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD MODEL 3093 N=1| PROGRAMMER MODEL 8840 N=1